HHS reviews Utah senator's request to reclassify islet cells as organs

Utah Senator Mike Lee has pressed the Department of Health and Human Services to reclassify pancreatic islet cells as organs rather than drugs, a shift he says would streamline transplants for Type 1 diabetes patients. Lee’s “Increase Support for Life-saving Endocrine Transplantation Act,” which seeks formal legislative reclassification, has not advanced in the Senate, prompting him to request administrative action from HHS Secretary Robert Kennedy.

An HHS spokesperson confirmed the agency is actively reviewing the request and appreciated Lee’s continued involvement on behalf of diabetics. The senator argues that HHS already has authority to make the change, potentially accelerating access to a therapy approved by the FDA in 2023 but limited to 20-30 procedures annually in the United States. While the reclassification would not eliminate the need for immunosuppression, supporters cite recent trial data showing patients can wean off external insulin. The outcome of HHS’s review could determine how quickly the transplant process is expanded.